NCT01930357

Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen

Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free (VRVg) in Comparison With the Human Diploid Cell Vaccine, Imovax® Rabies in a Pre-exposure Prophylaxis Regimen in Healthy Children and Adolescents Aged 2 to 17 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure regimen in healthy children and adolescents aged 2 to 17 years. Primary Objectives: * To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at D42, i.e. 14 days after the last vaccination. * To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group. Secondary Objectives: * To assess the clinical safety of each vaccine after each vaccine injection when administered in a pre-exposure schedule. * To describe the immune response induced by each vaccine 14 days after the last vaccination, i.e. at D42, and 6 months after the first vaccination * To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e. 14 days after the last vaccination.

Detailed description

Participants will receive a total of three vaccinations, one each at Day 0, Day 7, and Day 28, respectively, and will be assessment for immune response to rabies vaccine before the first injection (baseline titer), at Day 42, and at Month 6. Safety will be assessed in all participants up to 28 days after each injection. Serious adverse events and adverse events of special interest (AESIs) will be collected up to 6 months after the last injection.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Purified Vero Rabies Vaccine Serum Free (VRVg)	0.5 mL, Intramuscular (Day 0, Day 7 and Day 28).
BIOLOGICAL	Imovax® Rabies: Human Diploid Cell Vaccine (HDCV),	0.5 mL, Intramuscular (Day 0, Day 7 and Day 28).

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-08-01
• Completion: 2015-06-01
• First posted: 2013-08-28
• Last updated: 2017-04-25

Locations

2 sites across 1 country: Philippines